George Prethibha, Jagun Oladayo, Liu Qing, Wentworth Charles, Napatalung Lynne, Wolk Robert, Anway Susan, Zwillich Samuel H
Pfizer Inc., 66 Hudson Blvd. East, New York, NY, 10001, USA.
Mount Sinai Hospital, New York, NY, USA.
Dermatol Ther (Heidelb). 2023 Aug;13(8):1733-1746. doi: 10.1007/s13555-023-00937-9. Epub 2023 Jun 10.
Alopecia areata (AA) is an autoimmune disease with an underlying immuno-inflammatory pathogenesis. Treatments can include systemic corticosteroids and immunomodulators (such as Janus kinase inhibitors); these medications may be associated with a risk of some adverse events. However, large-scale observational studies of baseline incidence rates (IRs) of infection, cardiovascular disease, malignancy, and thromboembolism in US patients with AA, including those with alopecia totalis or alopecia universalis (AT/AU), are limited. This real-world, US claims-based study aimed to estimate the incidence of events in patients with AA compared with matched patients without AA.
Patients aged ≥ 12 years enrolled in the Optum Clinformatics Data Mart database from 1 October 2016 to 30 September 2020, with ≥ 2 AA diagnosis codes were included in the AA cohort. Patients without AA were age-, sex-, and race-matched 3:1 to patients with AA. Baseline comorbidities were evaluated during the 12-month period pre-index date. Incident cases of serious/herpes infections, malignancies, major adverse cardiovascular events (MACE), and thromboembolic events were evaluated post-index date. Data are presented using descriptive statistics, proportional percentages, frequencies, and IRs (calculated with 95% CI).
Overall, 8784 patients with AA, 599 of whom had AT/AU, were matched to 26,352 patients without AA. IRs per 1000 person-years among the AA and non-AA cohorts, respectively, were 18.5 and 20.6 for serious infections, 19.5 and 9.7 for herpes simplex infections, 7.8 and 7.6 for herpes zoster infections, 12.5 and 11.6 for primary malignancies, 16.0 and 18.1 for MACE, and 4.9 and 6.1 for venous thromboembolisms. Compared with patients with non-AT/AU AA, patients with AT/AU largely had higher IRs for most baseline comorbidities and outcome events evaluated.
Patients with AA had a higher IR of herpes simplex infection than the matched non-AA cohort. Patients with AT/AU generally had higher rates of outcome events than patients without AT/AU.
斑秃(AA)是一种自身免疫性疾病,具有潜在的免疫炎症发病机制。治疗方法可包括全身性皮质类固醇和免疫调节剂(如 Janus 激酶抑制剂);这些药物可能会带来一些不良事件的风险。然而,关于美国斑秃患者(包括全秃或普秃患者)感染、心血管疾病、恶性肿瘤和血栓栓塞的基线发病率(IR)的大规模观察性研究有限。这项基于美国索赔数据的真实世界研究旨在估计斑秃患者与匹配的非斑秃患者的事件发生率。
2016 年 10 月 1 日至 2020 年 9 月 30 日期间纳入 Optum Clinformatics Data Mart 数据库的年龄≥12 岁且有≥2 个斑秃诊断代码的患者被纳入斑秃队列。非斑秃患者与斑秃患者按年龄、性别和种族以 3:1 的比例匹配。在索引日期前的 12 个月期间评估基线合并症。在索引日期后评估严重/疱疹感染、恶性肿瘤、主要不良心血管事件(MACE)和血栓栓塞事件的发病病例。数据采用描述性统计、比例百分比、频率和发病率(计算 95%置信区间)呈现。
总体而言,8784 例斑秃患者(其中 599 例为全秃或普秃)与 26352 例非斑秃患者匹配。斑秃队列和非斑秃队列每 1000 人年的发病率分别为:严重感染 18.5 和 20.6,单纯疱疹感染 19.5 和 9.7,带状疱疹感染 7.8 和 7.6,原发性恶性肿瘤 12.5 和 11.6,MACE 16.0 和 18.1,静脉血栓栓塞 4.9 和 6.1。与非全秃/普秃斑秃患者相比,全秃/普秃患者在大多数评估的基线合并症和结局事件方面的发病率大多更高。
斑秃患者的单纯疱疹感染发病率高于匹配的非斑秃队列。全秃/普秃患者的结局事件发生率通常高于非全秃/普秃患者。